Evidence map›Paper›PMID 27056648›Full record

Trial reportIndian heart journal2016

Effect of tolvaptan on acute heart failure with hyponatremia--a randomized, double blind, controlled clinical trial.

Elangovan Shanmugam, C R Madhu Prabhu Doss, Melvin George, Amrita Jena, Muthukumar Rajaram, Balaji Ramaraj, Karthik Anjaneyan, B Kanagesh

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Indian heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 11 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 11 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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  7. Interventions for chronic non-hypovolaemic hypotonic hyponatraemia.The Cochrane database of systematic reviews · 2018
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Elangovan ShanmugamDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
C R Madhu Prabhu DossDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
Melvin GeorgeDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India. Electronic address: melvingeorge2003@gmail.com.
Amrita JenaDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
Muthukumar RajaramDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
Balaji RamarajDepartment of Community Medicine, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
Karthik AnjaneyanDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
B KanageshDepartment of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
SRM Institute of Science and Technology · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the efficacy of tolvaptan in acute heart failure with hyponatremia using a randomized double-blinded placebo-controlled study design.

backgroundTolvaptan is a selective vasopressin receptor 2 antagonist. There are no published clinical trials on the utility of tolvaptan in acute heart failure with hyponatremia in the Indian population.

methodsAfter screening and informed consent, 51 HF patients with hyponatremia were randomized using computer-generated randomization sequence to receive placebo or 15mg of tolvaptan for 5 days along with conventional medical therapy. The patient's perception of dyspnea using Likert score and the plasma sodium was measured at baseline and for the next 4 days.

resultsThere was a mean improvement in sodium concentration by 5mEq/L (p=0.001) in patients receiving tolvaptan, whereas no significant improvement was seen in the placebo group (p=0.33). Significant improvement in Likert score was observed in both the groups (p=0.001), even though there was no difference between both the groups. Dry mouth and thirst were the most commonly occurring adverse effects observed in both the groups. There were no significant hemodynamic changes with tolvaptan therapy.

conclusionTolvaptan at a dose of 15mg is effective in reversing hyponatremia in acute heart failure and may be a suitable option in these patients.

Indexed as

Acute DiseaseAdministration, OralAntidiuretic Hormone Receptor AntagonistsBenzazepinesDouble-Blind MethodFemaleFollow-Up StudiesHeart FailureHumansHyponatremiaMaleMiddle AgedSodiumTolvaptanTreatment OutcomeAntidiuretic Hormone Receptor AntagonistsBenzazepinesSodiumTolvaptanDyspneaHeart failureHyponatremiaRandomized clinical trialTolvaptan

Identifiers

PMID27056648
PMCPMC4824334
OpenAlexW2100594348

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.